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Objectives This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation. Background Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus. Methods Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed. Results Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI. Conclusions Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection. [ABSTRACT FROM AUTHOR]

Objective: Transapical aortic valve implantation (TAVI) may lead to obstruction of coronary arteries during deployment. To prevent this, it is essential to determine the distance of the coronary ostium to the aortic annulus prior to valve placement. Multidetector computed tomography (MDCT) commonly is used to determine these measurements, but even marginal exposure to contrast agents can result in acute kidney injury in this high-risk group of multi-morbid patients. The aim of the study was to determine the feasibility of real-time 3D transesophageal echocardiography (RT 3D TEE) as the first-choice technique for noninvasive evaluation of the coronary ostium during TAVI. Design: Retrospective study. Setting: University hospital. Interventions: Fifty patients underwent MDCT the evening before surgery. RT 3D TEE was performed intraoperatively before valve deployment. The dataset from both of these examinations was digitally stored and evaluated. MDCT was performed in nonanesthetized patients; however, in the RT 3D TEE group, general anesthesia was established. Measurements and Main Results: The distances from the right coronary artery and the left coronary artery ostium were measured retrospectively. Bland-Altman Plots and linear regression analysis showed excellent correlation between the 2 methodologies; intraobserver and interobserver variance were calculated using analysis of variance. Krippendorff's α indicated excellent agreement between the 2 observers (0.96 and 0.98) as well as between RT 3D TEE and MDCT (0.97 and 0.98). Conclusions: The observations showed that RT 3D TEE reliably can measure the coronary ostium distance from the aortic annulus. It is feasible and an alternative method for evaluating these measurements and thereby preventing contrast exposure during MDCT, which may jeopardize the safety of patients with pre-existing renal disease. [Copyright &y& Elsevier]

Objectives: This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation. Background: Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture. Methods: Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed. Results: Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up. Conclusions: Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results. [Copyright &y& Elsevier]

Objectives: This study assessed the rate of periprocedural embolic ischemic brain injury during transapical aortic valve replacement in 25 consecutive patients. Background: Transcatheter aortic valve implantation is rapidly being established as a new therapeutic approach for aortic valve stenosis. Although initial clinical results are promising, it is unknown whether mobilization and embolization of calcified particles may lead to cerebral ischemia. Methods: Twenty-five consecutive patients (10 men, 15 women, mean age: 81 ± 5 years, mean log EuroSCORE [European System for Cardiac Operative Risk Evaluation]: 32 ± 10%) scheduled for transapical aortic valve implantation were included. All patients received a baseline cerebral magnetic resonance imaging scan. The scan was repeated approximately 6 days after valve implantation. The magnetic resonance imaging studies included axial diffusion–weighted, T2-weighted, fluid attenuated inversion recovery–weighted, and T2 gradient echo sequences. Standardized assessment of the neurologic status was performed before aortic valve replacement and post-operatively. Results: Transapical aortic valve implantation was successfully performed in all patients. In 17 patients (68%), new cerebral lesions could be detected, whereas 8 patients showed no new cerebral insults. The pattern of distribution and morphology were typical of embolic origin. Despite the high incidence of morphologically detectable lesions, only 5 patients showed clinical neurologic alterations. Out of these patients, only 1 suffered from a permanent stroke. Conclusions: New embolic ischemic cerebral insults are detected in 68% of patients after transapical valve implantation. Clinical symptoms are rare and usually transitory. Larger trials will need to establish the clinical significance of asymptomatic ischemic lesions as well as the rate of ischemic events in patients undergoing transfemoral valve replacement. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 92-year-old male with severe symptomatic aortic stenosis, diabetes, and renal failure. The patient successfully undergone transapical coronary intervention while undergoing transapical catheter-based aortic valve implantation and was discharged with good condition from the hospital 0 days after the operation. It discusses coronary artery intervention through transapical approach.